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Guidelines for the Clinical Use of Radioactive Materials (RAM) and Radiation-Producing Machines (RPM)

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Guidelines for the Clinical Use of Radioactive Materials (RAM) and Radiation-Producing Machines (RPM) Guidelines for the Clinical Use of Radioactive Materials (RAM) And Radiation-Producing Machines (RPM) CPM 122 This guideline is intended as a resource document for the safe use of radiation in the clinical setting. If you have questions or comments, please contact the Office of Radiation Safety at (414) 805-6540. Revised March 2013 1 Section I: General Policies page Management Policy Statement 2 Radiation Safety Program [CPM.0120] Radiation Safety Committee 3 Radiation Safety Office (RS) 3 Authorized User 4 Staff 4 Section II: Medical Use Operating Policies Medical Use of Radiation/Radioactive Materials 4 Medical Events [RSO-008] 5 Reports of Medical Events 6 Sentinel Events - Fluoroscopy [CPM.0124] 7 Radiation Therapy Inpatients [RSO-200] 7 Medical Emergency Procedures of an Inpatient Following Therapeutic Dose of Radionuclides or Implantation of Radiation Devices 9 Death of an Inpatient Following Therapeutic Dose of Radionuclides or Implantation of Radiation Devices [CPM.0160] 10 Release of Patients [CPM.0125] 15 Records 15 Monitoring Radiation Dose [CPM.0123] 15 Radiation Exposure During Pregnancy [CPM.0121] 16 Surveys and Monitoring 18 Radioactive Material, Receipt of [CPM.0165] 18 Posting Requirements 18 Storage and Security of RAM/RPM 20 Syringe and Vial Shields 20 Processing I-125 Radioactive Seeds [RSO-501] 20 Section III: Use of Diagnostic Medical X-Ray Equipment Use of Diagnostic Medical X-Ray Equipment [CPM.0119] 20 X-Ray Radiation Protection [CPM.0118] 21 Revised March 2013 2 Section I: General Policies Management Control and Responsibilities Management Policy Statement Radiation Safety Program [CPM.0120] The Medical College of Wisconsin (MCW) is licensed by the State of Wisconsin, Department of Health Services (DHS) to use radioactive materials (RAM) for clinical and research applications at facilities located at Froedtert Memorial Lutheran Hospital (FMLH) and MCW. The RAM license is a broadscope license for the use of unsealed and sealed sources for clinical human use and biomedical research including for the use of cobalt-60 as sealed sources in teletherapy irradiators, biomedical research and for the use of cesium-137 as sealed sources for use in self-shielded irradiators for the irradiation of materials, e.g., small animals, biological samples, blood and blood products, excluding explosive and flammable materials. The Administrations of MCW and FMLH are responsible for the maintenance of the license and the activities governed by DHS. FMLH and MCW are jointly responsible for the implementation and review of a radiation safety program that conforms to DHS regulations, specific license conditions and other federal, state and local regulating agencies. The radiation safety program is directed and monitored by the Radiation Safety Committee (RSC). The RSC is an administrative committee responsible for the oversight of RAM under the licenses. The day-to-day operation of the radiation safety program is provided by the Radiation Safety Office (RS) under the direction of the Radiation Safety Officer (RSO). The RSO has been delegated the authority by FMLH and MCW administrations to address and resolve problems that could lead to noncompliance of regulations or DHS license conditions. The RSO is a member of the FMLH Environment of Care Committee for purposes of reporting and coordinating safety and emergency response activity. Radiation Safety Committee (RSC) The RSC is comprised of, but not limited to, the RSO, representatives from the administrations of FH and MCW, an authorized user from each type of use permitted under the license, a representative of the nursing service and ad hoc members deemed appropriate by the administration. The responsibilities of the RSC regarding the use of radioactive material (RAM) are to establish policies and procedures for the use of RAM at the facilities under the license approve or deny applications for the use of RAM and review the radiation safety program with the assistance of the RSO. Radiation Safety Office (RS) The day-to-day operation of the radiation safety program is conducted by the RS staff. The RSO oversees the RS and staff. The duties of the staff include monitoring RAM use, identifying radiation safety problems, verifying implementation of corrective actions and monitoring compliance with regulations. Revised March 2013 3 Additionally, the RS initiates, recommends, and/or provides corrective actions for areas of concern, and occurrences of noncompliance with DHS regulations or license conditions. The RS, under the supervision of the RSO, is delegated the authority necessary to assure the radiation safety requirements are met, including the stoppage of any operation deemed unsafe. Authorized User The medical use of radiation, either RAM or RPM, shall only be with the knowledge and approval of the RSC. Applications for such use shall be submitted to the RS for review by the RSC. An applicant shall be a physician licensed to practice medicine in the state of Wisconsin and meet the training criteria designated by Wisconsin Administrative Code, DHS 157. Staff Individuals who come into contact with RAM or ionizing radiation from RAM and/or RPM have certain rights and responsibilities according to state and federal regulations. These are outlined in the DHS Form PPH 45027 - Notice to Employees, and the accompanying Supplement to Notice to Employees. These documents are posted in locations where RAM and RPM are used or stored. Section II: Medical Use Operating Policies Medical Use of Radiation/Radioactive Materials The RSC shall approve authorized user physicians for medical use of RAM for diagnosis or therapy, and the therapeutic use of radiation (e.g., external beam teletherapy). Applicants must provide documentation of training and experience qualifications prior to approval by the RSC. The use of radiation-emitting products in a manner other than that specified in the Registry of Sealed Sources and Devices requires approval from the appropriate Institutional Review Board (IRB). All references in this manual to the term ‘patient’ refers to the patient or human research subject as referenced to in DHS 157. The medical use of radionuclides/radiation in procedures not requiring a written directive shall be performed in such a manner as to maintain radiation exposure to employees and the public as low as reasonably achievable and in accordance with DHS regulations, license conditions, and the departmental Policy and Procedure manual. The medical use of RAM/RPM requiring a written directive shall be performed in accordance with the written directive and in such a manner as to maintain radiation exposure to employees and the public as low as reasonably achievable. Specifically, radiation levels shall be maintained such that individual members of the public could not receive a radiation dose in excess of 0.02 mSv (2 mrem) in any one hour or 1 mSv (100 mrem) in one year. Patients having been administered doses of unsealed RAM or radioactive implants shall not be released from control unless the total effective dose equivalent to any individual member of the public from exposure to the released Revised March 2013 4 individual is not likely to exceed 5 mSv (500 mrem). Release of such patients shall be in accordance with DHS 157.62(8). Medical Events [RSO-008] Medical events are defined in DHS 157.72(1) for RAM and DHS 157.83(3) for RPM. A brief description is listed below, for full requirements; refer to the appropriate section of the DHS regulations: 1. A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 50 mSv (5 rem) effective dose equivalent, 500 mSv (50 rem) to an organ or tissue, or 500 mSv (50 rem) shallow dose equivalent to the skin; and a. The total dose delivered differs from the prescribed dose by 20 percent or more; b. The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or c. The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more. 2. A dose that exceeds 50 mSv (5 rem) effective dose equivalent, 500 mSv (50 rem) to an organ or tissue, or 500 mSv (50 rem) shallow dose equivalent to the skin from any of the following-- a. An administration of a wrong radioactive drug containing RAM; b. An administration of a radioactive drug containing RAM by the wrong route of administration; c. An administration of a dose or dosage to the wrong individual or human research subject; d. An administration of a dose or dosage delivered by the wrong mode of treatment; or e. A leaking sealed source. 3. A dose to the skin or an organ or tissue other than the treatment site that exceeds by 500 mSv (50 rem) to an organ or tissue and 50 percent or more of the dose expected from the administration defined in the written directive (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site). 4. Any event resulting from intervention of a patient in which the administration of RAM or radiation results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician, shall be reported in the same manner as a medical event. Any individual who knows of or suspects any occurrences that may meet the criteria listed above shall report such occurrences promptly to their immediate supervisor, the authorized user, Revised March 2013 5 authorized medical physicist, authorized nuclear pharmacist, or a radiation safety staff member, as appropriate. Such occurrences shall be evaluated as potential medical events. Reports of Medical Events In general, reports of medical events shall be made by the RSO or designee after consultation with the authorized user and authorized medical physicist/nuclear pharmacist, and a determination is made that an occurrence may constitute a medical event.
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